Greater Goods - BPM - PRO BPM - Greater Goods

Duns Number:189583599

Device Description: BPM - PRO BPM

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More Product Details

Catalog Number

-

Brand Name

Greater Goods

Version/Model Number

0632

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120058,K120058

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

436856bb-8f2f-412b-8834-64c02ae77a03

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 2021

Additional Identifiers

Package DI Number

10875011006320

Quantity per Package

12

Contains DI Package

00875011006323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON

"GREATER GOODS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 30